Muciclar 15 mg - nebulizing solution for acute bronchopulmonary diseases - 30 single-dose

Product Description

Indications

Secretion disorders in acute and chronic bronchopulmonary diseases.

Contraindications/Side effects

Hypersensitivity to ambroxol hydrochloride or to any of the excipients; severe liver and/or kidney disorders; taking the medicine is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients; the medicine is contraindicated in children under 2 years of age (for oral forms).

Dosage

Inhalation use. Nebulizer solution 15 mg/2 ml. Adults: 2-3 single-dose containers per day, children: 1-2 single-dose containers per day. For inhalation use, the contents of a single-dose container of medicine can exceed 15 mg/2 ml. It can be mixed in the dispenser with distilled water in a 1:1 ratio, thus obtaining optimal humidification of the air you breathe.

Warnings

Ambroxol should be administered with caution to patients with peptic ulcers. In very few cases, serious skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) have been observed simultaneously with the administration of mucolytic substances such as ambroxol. Most of these could be explained by the severity of underlying diseases or other concomitant medications. Furthermore, in the initial phase of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), patients may initially experience nonspecific flu-like symptoms, such as fever, chills, rhinitis, cough, and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold therapy may be initiated. If new skin or mucous membrane lesions occur, discontinue treatment with ambroxol as a precaution. During administration of the nebulized solution, since excessively deep inhalation of aerosols may cause an irritating cough, try to inhale and exhale normally during inhalation. In particularly sensitive patients, prewarming the inhaled solution to body temperature may be recommended. Patients with bronchial asthma should take a bronchial antispasmodic before inhalation. In cases of mild or moderate renal insufficiency, the drug should be used only after consulting a doctor. As with all drugs subject to hepatic metabolism and subsequent renal elimination, accumulation of ambroxol metabolites in the liver is expected in the presence of severe renal insufficiency. Mucolytics may cause bronchial obstruction in children under 2 years of age. In fact, the ability to drain bronchial mucus is limited in this age group, due to the physiological characteristics of the airways. They should therefore not be used in children under 2 years of age (for oral forms).

Interactions

Following the administration of ambroxol, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No interactions with other medicinal products have been reported.

Undesirable effects

The undesirable effects listed by frequency are reported using the following convention: very common (>=1/10); common (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (<1/10,000), frequency unknown. Immune system disorders: Not known: anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions. Nervous system disorders: Common: dysgeusia (e.g., altered sense of taste); rare: headache. Respiratory, thoracic and mediastinal disorders: Common: hypoaesthesia of the mouth and pharynx; rare: rhinorrhea; not known: bronchial obstruction. Gastrointestinal disorders: Common: nausea; uncommon: vomiting, diarrhoea, dyspepsia and abdominal pain, dry mouth; rare: heartburn, constipation; not known: dry throat. Skin and subcutaneous tissue disorders: Rare: rash, urticaria, contact dermatitis. Renal and urinary disorders: Rare: dysuria. General disorders and administration site conditions: Rare: fatigue.

Pregnancy and breastfeeding

Ambroxol crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonic/fetal development, parturition, or postnatal development. Although preclinical studies and extensive clinical experience have not shown any harmful effects on the fetus after the twenty-eighth week of gestation, it is advisable to take the usual precautions when taking medicines during pregnancy. Taking ambroxol is not recommended, especially during the first trimester. The medicine is excreted in breast milk, therefore the use of ambroxol is not recommended during breastfeeding. However, no negative effects on the infant are expected. During pregnancy and breastfeeding, the medicine should be administered only if strictly necessary.